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ISMP Medication Safety Alert


ISMP Quarterly Action Agenda - October - december 2008

From the January 29, 2009 issue

 One of the most important ways to prevent medication errors is to learn about problems that have occurred in other organizations and to use that information to prevent similar problems at your practice site. To promote such a process, the following selected items from the October-December 2008 ISMP Medication Safety Alert! have been prepared for an interdisciplinary committee to stimulate discussion and action to reduce the risk of medication errors. Each item includes a description of the medication safety problem, recommendations to reduce the risk of errors, and the issue number to locate additional information as desired. Look for our high-alert medication icon under the issue number if the agenda item involves one or more medications on the ISMP List of High-Alert Medications. The Action Agenda is also available for download in a Word format ( that allows expansion of the columns in the table designated for organizational documentation of an assessment, actions required, and assignments for each agenda item. Many product-related problems can also be visualized in the ISMP Medication Safety Alert! section of our website at:

Key: v  — ISMP high-alert medication

v Color-coded syringes for anesthesia drugs may result in mix-ups (25)
Problem: Color-coded syringes containing anesthesia drugs are available from repackaging companies. The colors are used to specify a particular drug class. We are concerned about potentially deadly mix-ups between various anesthesia drugs within a class, particularly if the color-coded syringes are available outside the OR.
Recommendation:  If your facility chooses to use these prefilled syringes, limit their use to the OR environment. Bar-coding systems would prevent most mix-ups, but if you don’t have this technology, work with anesthesia staff to limit the variety of drugs within a class. For example, purchase prefilled syringes for one opiate that is used most often, and require anesthesia staff to prepare other opiates and affix labels.

v Use “flag” labels on insulin pens instead of labeling the caps (22,23)
Problem: An insulin mix-up occurred when patient-labeled caps on insulin pens were accidentally switched.
Recommendation: Do not place labels on the caps of insulin pens. Although it’s difficult to label the body of the pen, it can be done using a “flag” or “tadpole labels,” which have a very narrow strip or clear portion that sticks to the container on one end, and a wider unglued surface on the other end for label information.

ISMP QuarterWatch report shows increase in adverse drug event (ADE) reports (21)
Problem: For a second quarter, varenicline (CHANTIX) accounted for more reported injuries than any other drug. Ranked second in serious injuries was heparin, the subject of a major recall. Other drugs on the top of the list include fentaNYL, interferon beta, inFLIXimab, and etanercept.
Recommendation: Make consumers aware of the risk of accidents associated with varenicline. Prescribers should weigh the risks associated with varenicline against the benefits, and consider alternative treatments when appropriate. Review your processes for recalled products to ensure that staff notification and removal of all the product occurs in a reliable fashion.

ADACEL (diphtheria and tetanus toxoids, acellular pertussis vaccine) and DECAVAC (diphtheria and tetanus toxoids) (20)
Problem: Prefilled syringes of Adacel and Decavac are fairly easy to differentiate when in their outer cartons. But once the syringes are removed from the boxes, the only label available is a set of peel-off stickers that look almost identical. The font size on the stickers is also very small, and the black plunger of the syringe makes the stickers difficult to read.
Recommendation: If your facility stocks both Adacel and Decavac syringes, affix an auxiliary label to the inner packages that hold the syringes to help differentiate the two products once removed from their outer cartons.

Flumazenil mistaken as flu vaccine (21)
Problem: A nurse couldn’t find a unit-dose syringe of flu vaccine in the automated dispensing cabinet (ADC) because pharmacy had removed the supply due to a recall. She thought flumazenil was also “flu” vaccine, so she used the override feature to obtain a vial. A pharmacist on the unit noticed the error after the nurse asked if she should return the rest of the “flu” vaccine vial to the ADC.
Recommendation: Have pharmacy dispense vaccines as they are ordered. When drug names appear sequentially on selection screens, consider whether warnings to alert users to possible errors would be helpful. While it may be appropriate for the removal of flumazenil from an ADC, the override feature should not be used for vaccines. Pharmacy should post a note about products removed from stock due to a recall.

Use of “IU” on label risks accidental IV administration of topical thrombin products (22,25)
RECOTHROM, a newer topical thrombin recombinant product, uses the abbreviation “IU” for international units on its label. “IU” is an abbreviation that should never be used because it has sometimes been misread as IV. Extensive intravascular clotting and death may result if topical thrombin is injected intravascularly.
Recommendation: Information about topical thrombin—including dose, route, and safe storage (see the FDA Patient Safety News video on the drug)—should be included in the competency validation of staff who work where this product might be used. Make rounds to areas where this drug might be stored to see firsthand how the drug is being used and to assure proper labeling. Have pharmacy prepare and label the drug when possible. Zymogenetics plans to eliminate use of IU on Recothrom product labeling.

Pint-size concentrated acetaminophen (PEDIAPHEN) may be confused with conventional strength acetaminophen (23)
Pint-sized bottles of Pediaphen concentrate (80 mg/ 0.8 mL) have been relabeled to reduce confusion with conventional children’s liquid acetaminophen (160 mg/5 mL). The revised label reduces the risk of mix-ups between the concentrate and conventional strengths, but confusion is still possible, as concentrated products often come in smaller containers.
Recommendation: Limited quantities and affordances (e.g., small dropper bottle, cusps around the bottle opening to prevent pouring the medication into a cup) are important safety features because they cue practitioners that small volume dosing is required. If you decide the features of this pint-sized container outweigh the safety risks, please take precautions (e.g., use in pharmacy only) to prevent errors.

Labeling of antihemophilic factor (recombinant) does not make it clear that these products are factor VIII (23)
The carton and vial labeling of recombinant antihemophilic factor (e.g., KOGENATE FS) does not indicate that the product is factor VIII, which is used to treat hemophilia A. The products are labeled correctly as antihemophilic factor (recombinant), but this may be too general, as factor IX is also an antihemophilic factor, which is used to treat hemophilia B.
Recommendation: Use auxiliary labeling to list “factor VIII” on the product labels of antihemophilic factor (recombinant) to reduce the risk of an error. To encourage label changes, we’ve communicated our concern to Bayer and the FDA Center for Biologics Evaluation and Research (CBER).

BACTRIM (sulfamethoxazole and trimethoprim) induced hyperkalemia (24)
The trimethoprim component in Bactrim causes a potassium-sparing effect, much like the potassium-sparing drug amiloride.Trimethoprim blocks sodium channels (particularly amiloride-sensitive sodium channels) in the distal tubule of the nephron. This blockade inhibits potassium secretion into the urine, leading to reabsorption in the blood and possible hyperkalemia.
Recommendation: Prescribers, pharmacists, and nurses need to be aware of this adverse effect of Bactrim. Obtain a baseline BUN/creatinine, adjust the dose if renal impairment exists, and periodically monitor potassium levels in patients at risk for hyperkalemia and those taking high doses of the medication. These recommendations should also be included as reminders in pharmacy computer systems and electronic prescribing software.

New staff intimidation contributes to fatal error (22)
New staff, new graduates, and others may believe they need to “prove” themselves in order to gain the trust and respect of their coworkers. A patient received a fatal overdose of sodium bicarbonate because a new pharmacist was too embarrassed and insecure to ask for help when compounding the product.
Recommendation: The code of conduct in an organization should promote an atmosphere where questions are expected and rewarded, regardless of staffs’ rank, experience, or education. Other important steps to help reduce intimidation in the workplace can be found in the 2004 March 11 and March 25 issues of this newsletter ( and at

Digitek Class I recall (24)
In April, all lots of Digitek (a branded generic digoxin product manufactured by the Actavis Group and dis-tributed by Mylan Pharmaceuticals under the Bertek and UDL Labs labels) were recalled because the tablets could have twice the intended drug. Num-erous deaths have been linked to the recalled tablets.
Recommendation: Please check your inventory and remove any Digitek tablets from storage. To return the recalled product, call 888-277-6166.

KERR INSTA-CHAR charcoal product in sorbitol needs auxiliary labeling (24)
A pharmacist almost dispensed charcoal in sorbitol (Kerr Insta-Char) instead of an aqueous base. Kerr Insta-Char has a straw and cherry-flavor ampul attached to the bottle, which makes it hard to see the label clearly. The use of sorbitol, even when administered as indicated for only the first dose, is controversial since it could lead to diarrhea, cramping, and fluid and electrolyte loss—a particular concern in children.
Recommendation: If you have these products in stock, consider affixing an auxiliary label to identify the presence or absence of sorbitol. If the products are available in automated dispensing cabinets, you also might want to make a cautionary note visible on the screen (e.g., contains sorbitol, first dose only). We have contacted the maker of Kerr Insta-Char to ask them to enhance recognition of sorbitol on the label.

Hand sanitizers may be ingested by patients with a history of alcohol abuse (24)
A hospitalized patient with a history of alcohol abuse was witnessed on two occasions ingesting AVAGARD foam hand antiseptic from a wall dispenser.
Recommendation: When high-risk patients with a history of alcohol abuse are hospitalized, consider temporarily removing the alcohol-based hand sanitizers from nearby wall dispensers

Levetiracetam and levofloxacin mix-up (25)
A nurse did not have her patient’s next scheduled dose of levetiracetam, so she notified the pharmacy by electronically initiating a reprint of the label. The label printed in the “central” pharmacy (not in the IV room), where a technician misread it as levofloxacin 750 mg IV. The error was related to name similarity of the two products and overlapping dosages.
Recommendation: Ensure that a label for any product that requires compounding is printed in the IV preparation area where it is made, not the central pharmacy. Pharmacists should also review the patient’s profile before dispensing any missing doses to a patient care unit. Ensure that labels generated by nurses can be clearly identified as a missing medication request.

Mix-ups between CARAC (fluorouracil) and KURIC (ketoconazole) (21)
Sanofi-aventis distributed a letter to pharmacists regarding the risk of mix-ups between its Carac cream and Altana’s Kuric cream. The letter was sent after an error caused by a verbal order for Kuric that was misheard as Carac. The involved patient developed a rash and infection.
Recommendation: Prevent confusion by clarifying oral and written orders, verifying the brand and generic names, spelling the product name when reading back oral orders, matching the product’s indication to the patient’s condition, and drawing attention to the differences in the names of these products. An ISMP website that alerts consumers to drug safety issues   (25)
Problem: is the first and only website exclusively designed to bring the message of adverse drug event prevention to consumers ( This website provides patients with a trusted Internet source from which to learn about error prevention, report their experiences with errors and side effects, and share their opinions about drug effectiveness
Recommendation: Hospitals can link their websites to ConsumerMed- and encourage their patients (and staff) to take advantage of a unique system that sends personalized safety alerts to consumers based on the medications they take at home.

ISMP gains PSO status   (22)
As of November 5, 2008, ISMP is a federally certified Patient Safety Organization (PSO). Reporting errors or safety information to a PSO confers both privilege and confidentiality so that the information is protected and cannot be used against an organization or its staff in the event of a lawsuit.
Recommendation: Practitioners should continue to report medication errors to ISMP as they have in the past. Safety/quality committees in organizations can also work with ISMP to analyze risk, adverse events, and aggregate data to help improve safety. Information (not medical records) provided to ISMP for the purpose of improving safety is afforded the full protection of a PSO

Debora Simmons is an approved California CE provider of continuing education and complies with the criteria for quality continuing nursing education programming.

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